Pharmacovigilance Scientist, Senior Manager

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Pharmacovigilance Scientist, Senior Manager

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What you will do

Let’s do this. Let’s change the world. The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the safety strategy and major safety deliverables for each Amgen product. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations.

In this vital role you will work with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations and provide scientific and compliance expertise as needed to GPS.

Responsibilities:

• Directs the planning, preparation, writing and review of portions of aggregate reports
• Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products
• Supports and provides oversight to staff with regards to safety in clinical trials

Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents.

• Review of AEs/SAEs from clinical trials as needed
• Review standard design of tables, figures, and listings for safety data from clinical studies
• Participate in development of safety-related data collection forms for clinical studies
• Participate in study team meetings as requested or needed
• Signal detection, evaluation, and management- Perform data analysis to evaluate safety signals and write up analysis results
• Documents work as required in the safety information management system
• Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO
• Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
• Prepare presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body

Assist GSO in the development of risk management strategy and activities:

• Provides contents for risk management plans
• Develop or update strategy and content for regional risk management plans
• Assist GSOs with aspects of risk minimization activities including tracking of activities as needed.
• Evaluate risk minimization activity
• Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO
• Support activities related to new drug applications and other regulatory filings
• Assist GSO in developing a strategy for safety-related regulatory activities
• Provide safety contents for filings

Inspection Readiness:

• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
• Processes and regulations for pharmacovigilance and risk management
• Drug development and lifecycle management
• Safety data capture in clinical development and post-market settings
• Safety database structure and conventions
• MedDRA and other dictionaries used in pharmacovigilance
• Methods of qualitative and quantitative safety data analysis
• Inter-relationship across various pharmacovigilance processes and documents, including reference safety information and product labeling

Pharmacovigilance skills-intermediate knowledge of the following:

• Signal detection, evaluation and management
• Aggregate data analysis, interpretation and synthesis
• Application of medical concepts and terminology
• Document writing and source document review
• Writing Risk Management Plans
• Ability to convey complex, scientific data in an understandable way
• Ability to analyze and interpret complex safety data
• Intermediate skills in application of statistical and epidemiological methods to pharmacovigilance

Biomedical Literature-intermediate skills: